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MAPS PBC Announces Positive Topline Results from Long-Term Observational Follow-Up Study on MDMA-Assisted Therapy for Treatment of PTSD

  • Interim results show improvements in PTSD symptom severity lasted at least six months after the last treatment session 
  • Findings are consistent with previously published Phase 2 data1 on the sustained effect of MDMA-assisted therapy for the treatment of PTSD

Excerpt from the Press Release:

SAN JOSE, Calif., April 5, 2023 /PRNewswire/ — MAPS Public Benefit Corporation (“MAPS PBC”), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced positive topline results from an observational follow-up study evaluating the long-term safety and efficacy of MDMA-assisted therapy for post–traumatic stress disorder (“PTSD”). Preliminary findings show that participants in this study demonstrated a durable response at least six months, and in some cases a year or more, after their final MDMA-assisted therapy session during the Phase 3 study.

“PTSD is a chronic condition when insufficiently treated and has historically been addressed through long-term maintenance treatment, which is why it’s important to evaluate whether an acute treatment like MDMA-assisted therapy has an enduring response when used to treat PTSD,” said Amy Emerson, chief executive officer, MAPS PBC. “These results are consistent with previously published Phase 2 data demonstrating the sustained effect of MDMA-assisted therapy at least 12 months following treatment and suggest the acute treatment effect could last even longer.”

In the two Phase 3 studies, participants who received therapy with MDMA showed significant improvement over therapy with placebo when measured at two months after the last experimental session, meeting the primary and secondary endpoints.

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